Posted on April 28th, 2009 by
Class: Supportive care
Generic Name: Palifermin (pa-li-FER-min)
Trade Name: Kepivance™
For which conditions is this drug approved? Palifermin is FDA-approved to decrease the incidence or duration of severe oral mucositis in patients who have cancers affecting the blood (hematologic) and who will undergo treatment including a stem cell transplant. Oral mucositis is a condition that can be caused by treatment for cancer and it affects the lining of the mouth. Oral mucositis may result in a range of symptoms, including pain or irritation of the mouth, or severe ulceration in the mouth. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Palifermin belongs to a class of drugs called growth factors. Palifermin stimulates cells, called epithelial cells, to grow and divide. Epithelial cells comprise the outer layer of the mouth, and other digestive organs; therefore, stimulation of their growth helps reduce oral mucositis.
How is palifermin typically given (administered)? Palifermin is administered intravenously (into a vein) and the dose depends on the size or weight of the patient. Palifermin is given in 3 doses prior to therapy and 3 doses following therapy. Palifermin should not be administered within 24 hours of chemotherapy administration.
How are patients monitored? Patients will undergo assessments for oral mucositis. This may include the physical examination of the mouth, lips, gums, and tongue, as well as questions posed to the patient regarding pain, ability to swallow, ability to eat and drink, etc.
What are the most common side effects associated with treatment with palifermin?
What can patients do to help alleviate or prevent discomfort and side effects?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician?
What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
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